1. Field of the Invention
This invention relates to the field of enteral and medical fluid product delivery connectors and related systems.
2. Description of Related Art
Fluid delivery, flowable product, and substantially liquid product delivery systems for enteral applications in the nutritional, nutraceutical, and medical fields are available in many variations. Such delivery systems most often include a fluid source, receptacle, rigid or flexible bottle, soft pouch, collapsible bag, or other type of container configured to contain an enterally administered flowable substance such as a liquid or fluid.
Such containers are either (1) filled with a fluid and sealed at a factory before delivery to a user, or (2) is delivered ready for filling by the user and/or fluid recipient. When delivered ready for filling, the containers may be empty, and may also include a concentrate, precipitate, or a fluid that can be mixed and/or hydrated with another liquid, fluid, and/or flowable or powdered substance or product by the user and fluid recipient.
For purposes of describing the instant invention, but not for purposes of limitation, all such containers will be referred to herein generically as bottles and/or collapsible bags. All such flowable substances, products, liquids, fluids, and other contents to be enterally administered will be generally referred to as liquids and/or fluids for purposes of illustration without limitation.
Those skilled in the relevant arts have conventionally categorized such enteral fluid delivery systems and containers into two general groups. The factory filled and sealed containers are usually described to be closed systems, which means they are delivered to users and recipients in a sealed state. The fluid delivery systems and containers that are delivered ready for filling by users and recipients are usually described as open systems. delivered to users and recipients in a sealed state. The fluid delivery systems and containers that are delivered ready for filling by users and recipients are usually described as open systems.
These delivery systems also typically include liquid administration and/or fluid delivery sets that typically incorporate a length of tubing that has a plurality of connectors. At a minimum, the connectors often include a connector adapted to connect to and establish fluid communication with the fluid container, and tubing extending to a fluid recipient and/or one or more other connectors for communicating the fluid to the recipient.
Such enterally adapted liquid product or fluid delivery systems are substantially different from what are known to those skilled in the relevant arts as intravenous (IV) fluid delivery systems. Most often, the primary difference is that the enteral systems are capable of delivering higher density and/or more viscous fluids to the recipient than is possible with IV systems.
To accomplish the delivery of such more dense and viscous fluids, enteral fluid delivery systems usually include fluid pathways formed from tubing, connectors, and fitments that have larger internal diameters. Such connectors and tubing are typically made from various polymeric materials suitable for the contemplated enteral liquid and fluid products. The larger diameter fluid pathways also enable communication of enteral fluids more rapidly to the recipient than is possible or indicated for IV fluid delivery systems. IV fluids are typically administered over substantially longer spans of time than is usually desired for the delivery of enteral liquids, and can often be accommodated with smaller fluid pathways. Administration of enteral products may use such smaller fluid pathways, but are more often intended for delivery in indwelling applications to communicate more viscous and dense fluids more rapidly, which is facilitated by the larger diameter pathways.
Referring to the various figures and illustrations, and especially now to FIG. 1, an elevation view is shown of a prior art, prefilled, closed-system collapsible fluid pouch or bag B, which is also referred to by those in the field of art as a ready-to-hang (RTH) pouch or bag B. In alternative arrangements, the bag may also be used in an open system that is delivered empty and fillable by a user or fluid recipient.
The bag B includes a sidewall or walls SW that defines an interior volume V. Although in these various figures, the interior volume reference symbol V points to a surface of the bag B, it is assumed for illustration purposes without limitation that the substantially collapsible bag is made from a substantially transparent polymeric material such that the reference symbol adequately designates the interior volume of the bag B.
The bag B extends to a neck N having a finish F terminated with a rim R that defines a fluid communication port P about a proximal end of the bag B. The finish F may incorporate threads TH, and/or other types of attachment system. In a closed-system configuration, a sealed septum, sealing membrane, or seal (not shown) may be carried from the rim R after the bag B has been filled aseptically, and before retort processing as may be preferred.
Before use, the seal or membrane will be punctured or pierced, or removed entirely or partially, and the bag B will be connected to an end cap or cap C. The end cap or cap may be integrally attached to or adapted to be connected with an administration set AS. Typically, collapsible containers like bag B do not require vented caps C as the bag B collapses during operation as the contents are dispensed.
Since administration sets AS may be used for multiple types of containers, cap C may also preferably include a vent VT to equalize pressure between an interior of the container or bag B and the external atmosphere as the contents are administered. This capability is required to enable fluid to leave a rigid container that cannot flex or collapse to equalize pressure as fluid leaves the interior volume V.
The set AS will also include a lumen or tube T that extends to other connectors or a fluid recipient. During operation, the assembled RTH bag B and cap C may be hung from a gravity or elevation pole GP to administer or deliver fluids to the recipient. The intent of the GP is to raise the bag B higher than the fluid recipient to establish a head pressure on the liquid contained in the bag B that is sufficient to administer the liquid to the fluid recipient during gravity dispensement operation.
FIG. 2 is an elevation view of a prior art RTH, fillable, open-system, collapsible, and substantially transparent, polymeric bag B′ that might be used for administration of enteral or intravenous (IV) fluids. This configuration is typical of open systems which often include a second bag port BP about a distal end of the bag B′, which second bag port BP is most often and generally opposite the proximal end that carries the port P′. In alternative arrangements, the bag B′ may also be used in a hybrid open-closed system wherein the bag is delivered with a concentrate that is hydrated or mixed with other components a user may desire to add for administration with the system.
In the configuration depicted in FIG. 2, the bag B′ also includes a sidewall SW′ that encloses an interior volume V′ for containing a fluid. The bag B′ further incorporates a neck N′ with a finish F′ terminating in a port P′. The post P′ may include an end cap or connector CN′ and sealed with removable and/or pierceable seal S′, which seal S′ may be formed from a pierceable septum.
In this arrangement, the seal or septum S′ is penetrated to communicate fluid, typically an intravenously administered fluid, with a legacy spike LS′ having a distal extent D′ formed with a sharp or substantially pointed end E′ formed as a legacy spike diameter SD′ ramps down to the pointed end E′, many types of which are well-known to the various IV fields of art. The legacy spike LS′ forms a part of an administration set AS′ and may be carried from a connector C′ that is in fluid communication with a tube T′ that extends to a fluid recipient. A user or fluid recipient may pierce the seal or septum S′ with the legacy spike S′ to establish the fluid communication.
Referring next to FIG. 3, another variation of RTH receptacles is shown. Here an RTH rigid bottle B″ is depicted, which also includes a sidewall SW″ that encloses an interior volume V″ for containing a fluid. The rigid bottle B″ may be used in open and closed system configurations and will incorporate a neck N″ extending to a finish F″ terminating in a rim R″ that defines a fluid communication port P″. The finish F″ may carry or integrally incorporate an end cap or connector CN″ that may define the port P″. The port P″ may be sealed with a removable or pierceable sealing membrane, seal, and/or septum S″.
Here again, an administration set AS″ may include tubing T″ extending to a fluid recipient to communication fluid from the rigid bottle B″. A connector C″ is typically connected to the tubing T″ and may carry a legacy spike LS″, which can pierce the seal or septum S″ to establish the fluid communication.
With continued reference to the various figures, and now also to FIGS. 4, 5, and 6, further enlarged views of certain prior art components are depicted for further illustration. FIG. 4 is an enlarged view of the rigid bottle of FIG. 3, which shows the neck N″ and finish F″ of the bottle B″, and with the rim R″ carrying the fluid seal membrane or septum S″ affixed to the rim R″.
The detail view of FIG. 5 shows an enlarged view of the neck N″, rim R″, port P″, and seal or septum S″. Cross-sectional view 6-6 illustrates the relationships of these components. View 6-6 also shows the seal or septum S″, to have a low-internal-pressure-induced, curved lower surface as may be used with film seal membranes and seals S″ that seal the interior volume V″ in a vacuum. View 6-6 also identifies an additional seal or septum material SM, which can extend within neck N″ much like a stopper or cork used in other applications.
Despite many attempted improvements over the years, manufacturers, distributors, consumers, and users of such fluid receptacles, containers, bottles, bags, and the connector assemblies and administration sets have continued to experience a number of difficulties and challenges, and continue to strive for improvements.
In one example of such challenges, users and fluid recipients have been known to use administration sets and components inadvertently that are intended for IV fluid administration with enteral fluid administration products. This has resulted in frustrated fluid recipients and users that have been thwarted in their attempts to administer enteral fluids.
Those having skill in the field have recognized that the smaller fluid pathway diameters of IV administration sets, connectors, and systems are unsuited for rapid enteral indwelling delivery of more viscous and dense enteral fluids. Those attempting to interconnect IV fluid administration connectors, systems, and administration sets to enteral fluid containers, receptacles, bottles, pouches, and bags, have also experienced fluid leaks that waste valuable enteral products.
Additional frustrations can be experienced by users and fluid recipients that attempt to administer IV fluids using incompatible enteral administration sets, connectors, and systems. Such incompatible and unintended uses, applications, and circumstances create obstacles to effecting otherwise desirable administration of desired fluids at preferred flow rates to fluid recipients, and may also introduce leaking of valuable IV products unintended for delivery and administration using such enteral fluid delivery systems.
One of the problems that has been seen is that legacy IV spikes such as legacy spikes LS′, LS can sometimes be forcibly introduced into enteral connectors, systems, and administration sets. While many variations of such legacy IV spikes LS′, LS″ have found their way into the marketplace, a substantial majority of such legacy IV spikes are usually in the range of about 1.00 inches to about 1.25 inches in length from shoulder to pointed tips. Such legacy IV spikes are also usually formed to have a diametrical diameter that is approximately between about 0.250 and about 0.375 inches.
In enteral administration sets, connectors, and systems that use the aforementioned seals and septums, there are limited means by which to prevent an unskilled user or fluid recipient from ignoring incompatibility issues and the undesirability of using inappropriate combinations of components. Further, prior components can present inconveniences wherein legacy spikes may puncture a seal, septum, and/or sealing membrane, such as a polymeric or plastic or foil seal, in a way that causes the seal, septum, and/or sealing membrane to seal against the exterior diameter of the legacy spike after puncture or piercing. Another challenge to users and fluid recipients includes the legacy spike causing particles or pieces of the seal, septum, and/or sealing membrane to separate during piercing and puncture and thereafter becoming lodged and impeding fluid communication in a fluid pathway.
Some manufacturers have attempted to introduce features to prevent users and fluid recipients from employing inappropriate combinations of connectors and systems in untoward, incompatible applications. Some such features were aimed at introducing proprietary connection components that cannot accept connectors from other manufacturers.
However, this approach often only compounded the frustrations experienced by users and fluid recipients who experienced leaks when forcibly connecting the incompatible components. Even with seemingly compatible components from assertedly cooperative manufacturers, such prior components have offered challenges to the users.
One challenge that has persisted as reported by such users includes that it is often impossible even for skilled users and fluid recipients to discern when connectors are properly joined together to establish fluid flow. These same and additional users have also repeatedly voiced concerns that the prior art connectors make it difficult to assemble even cooperative components in view of the manufacturer introduced, proprietary connector complexities, which purport to prevent incompatible connections.
Those with knowledge in the field of enteral administration sets, connector assemblies, and systems have long sought to create new components and systems that address the need to prevent incompatible connections, but which do not impose added challenges to the user and fluid recipients. Despite the prior art advances in many areas of connector design that have attempted improved connectability, designers have also sought improved ways to replace unintuitive complexities with intuitively easy-to-use features that reduce user confusion.
What has long been needed in the field of art of enteral connector assemblies and systems is a connector assembly and system that addresses the many issues surrounding prior designs. More specifically, an improved connector assembly and system is needed to increases the probability that experience and inexperienced users and fluid recipients will be unable to establish fluid connections between inappropriate connectors, systems, and administration sets. Even more preferably, it is important to enable users and fluid recipients to have increased confidence during operation of such connector assemblies and systems that they have properly connected components and properly established fluid communication.
Even in view of the many attempts in the prior art to produce effective enteral fluid delivery sets that include connector assemblies and systems, manufacturers, distributors, users, fluid recipients, and those skilled in the relevant fields of technology have remained convinced that further improvements are possible. The market continues to seek improved and easier-to-use connector assemblies and systems that are substantially less susceptible to being forcibly introduced into incompatible and inappropriate applications. Under ideal circumstances, such improvements would also incorporate all of the advantages of the prior art, while withstanding the unexpected and incompatible, forcible use attempts.